Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Allergan

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: normal saline; Biological: onabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910845

191622-095

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Enrollment: 557 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
• Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion criteria

• Overactive Bladder caused by neurological condition
• Patient has predominance of stress incontinence
• History or evidence of pelvic or urological abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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557 participants in 2 patient groups

onabotulinumtoxinA

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).

Treatment:

Biological: onabotulinumtoxinA

placebo/onabotulinumtoxinA

Other group

Description:

Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).

Treatment:

Drug: normal saline

Biological: onabotulinumtoxinA